W7?m7 mm 1s12020( Pmt2) :1* ( Reaffirmed 1995) ( Reaffirmed 2006 ) f%fkmaw a!l'?r %1''W%? q?mmW&iWmiR Indian Mmdurd MEDICAL ELECTRICAL EQUIPMENT ­ ULTRASONIC THERAPY EQUIPMENT PART 2 C(NWTRW7JGNAL Am ~RFORMAf$CE IIEaUIREMENTS UDC 615"837'3:620'16 @ BIS 1991 BUREAU MANAK March 1991 OF BHAVAN, lND IA& ST AEDARDS ZAFAR MARG Price Group 1 9 BAHADUR SHAH NEW DELHI 11(XM2 Electromedical Equipment Sectional Committee, MHD 19 FOREWORD This Indian Standard ( Part 2 ) was adopted by the Bureau of Indian Standards on 20 June 1990, after the draft finalized by the Electromedical Equipment Sectional Committee had been approved by the Medical Equipment and Hospital Planning Division Council. This standard has been formulated into two parts; Part 1 specifies the particular the safety, and Part 2 specifies performance and constructional requirements. requirements for The specified accuracy of f 30 percent is considered to provide for an adequate degree of safety and also takes into account the errors inherent in ultrasound power measurements. The temporal peak intensity of the modulated or pulsed mode is normally the intensity of the continuous mode, the average intensity of the modulated wave is, therefore, always less. The requirements for accuracy of operating data have been specified in .the standard. The maximum effective intensity for'this equipment specified as 3W/cms is well established in clinical practice as safe for general use. However, lower values dependent on the clinical application used may be necessary for particular treatments. In the preparation of this standard, assistance has been derived from IEC 601-I-1988 `Medical electrical equipment, Part 1 General requirements for safety' and IEC 6.0-l-2-5-1984 `Medical electrical Equipment, Part 2 Particular requirements for safety of ultrasonic therapy equipment', issued by the International Electrotechnical Commission ( IEC `1. For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test, shall be rounded off in accordance with IS 2 : 1960 `Rules for rounding off numerical values ( revisd).' The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard. 1s 13020 ( Part 2 ) : 1990 Indiau2Standard MEDICALELECTRICALEQUIPMENTULTRASONICTHERAPYEQU-IPMENT PART 2 CONSTRUCTIONAL AND PERFORMANCE REQUIREMENTS 1 SCOPE 1.1 This standard ( Part 2 ) specifies constructional requirements of ultrasonic and performance therapy equipment. ment shall be made immediately after any warmup period specified in the instructions for use. 5 PROTECTION OUTPUT AGAINST INCORRECT 2 REFERENCES 2.1 The following Indian Standards adjuncts to this standard: IS No. 5.1 Internal Exceeding of Safety Limits are necessary If the control range of equipment is such that the delivered output in a part of the range differs considerably from the output which is regarded as non-hazardous, means shall be provided which prevent such a setting or which indicate to the operator ( for example, by means of an apparent additional resistance when the control is set or the bypassing of an interlock or by an additional special or audible signal ) that the selected setting is in excess of the safety limit. 5.1.1 Test Compliance shall be checked by inspection. 5.2 Indication of Parameters Relevant to Safety Title 8607 ( Part 1 ) paration ) 8607 (Part Medical electrical equipment requirements for General safety: Part 1 Terminology ( first revision > ( under pre- 10) preparation ) Medical electrical equipmentfor requirements General Part 10 Abnormal safety: operation and fault conditions, test ( under environmental Medical electrical equipmentrequirements for General safety: Part 11 Constructional requirements ( under preparation ) 8607 ( Part I I ) The effective intensity shall not exceed 3 W/cm2 with any treatment head or adaptor provided by the manufacturer. In the case of a modulated waveform, the temporal peak intensity shall not exceed the above value. 5.2.1 Test Compliance shall be checked by the measurement of effective radiating area and measurement of effective ultrasound output power as in 4.1. The temporal peak intensity may be calculated from the value of the effective intensity and the measured parameters of the modulated waveform. 5.3 Equipment shall inCorporate a means ( an output control ) to enable the effective ultrasound output power to be reduced to not more than 20 percent of the rated output power. 5.3.1 Test Compliance shall be checked by the measurement of the effective ultrasound output power as in 4.1. 5.4 The measured maximum effective ultrasound output power shall not vary by more than t-20 percent for variations of the main supply voltage of * 10 percent. 5.4.1 Test Compliance shall be checked by the measurement 1 (c NOTE - Till such time the above mentioned standards are processed the matter sh?ll be as agreed to between the concerned parties. 3 TERMINOLOGY 3.1 Definitions as given in IS 8607 ( Part 1 > shall apply. 4 ACCURACY OF OPERATING DATA 4.1 Means shall be provided for the indication of effective ultrasound output power or the effective intensity or, in the case of modulated waveforms, the temporal peak intensity. The measured values shall not deviate from those indicated by more than + 30 percent for outputs in excess of 10 percent of the rated value. 4.2 Test Compliance shall be checked by the measurement of ultrasound output power by any method having an error not exceeding 10 percent or in the case of modulated waveforms by measurement and calculation as specified in 5.2. The above measure- IS 13020 ( Part 2 ) : 1990 of the effective ultrasound output power as in 4.1 at 90 percent, 100 percent and 110 percent of the rated value of the supply voltage. . , high intensity output being selected accidently; for example, interlocks in order to achieve deliberate action, separated output terminals. 6 FAULT CONDITIONS CAUSING OVERHEATING AND/OR MECHANICAL DAMAGE; ENVIRONMENTAL TESTS Provision apply. as given in IS 8607 ( Part 10 ) shall REQUIREMENTS 5.5 Equipment shall be provided with an adjustable timer which de-energizes the output after a preselected operating period. The timer should have a range not exceeding 30 minutes and an accuracy of-t 1 minute. 5.5.1 Test Compliance shall be checked funct:onal test. by - inspection _ and 7 CONSTRUCTIONAL 7.0 Provision and additional apply. 5.6 For treatment heads having a flat circular radiating surface with a diameter not less than 2 cm the intensity ratio shall not exceed the value of 2. 9.6.1 Test Compliance shall be checked by the measurement of maximum and effective intensity by any suitable method having an error not exceeding 10 percent. 5.7 Accidental Values Selection of Excessive Output as given in IS 8607 ( Part 11 ) requirements specified in 7.1 shall 7.1 Components and General Assembly 7.1.1 Terminals and Connectors The connecting cord of the treatment head shall be protected against excessive bending at the entries into the treatment head and into the equipment or the pertaining connection plug, respectively. 7.1.2 Test Compliance shall be checked by the application of the test for mains cords to the two ends of this connection cord. Where equipment is a multipurpose unit designed for providing both low-intensity and high-intensity outputs for different treatments, appropriate steps shall be taken to minimise the possibility of a 2 Standard Mark The use of the Standard Mark is governed by the provisions of the Bureau ofIndian Standards and Regulations made thereunder. The Standard Mark on products covered by an Indian Standard conveys the assurance that they have been produced to comply with the requirements of that standard under a well defined system of inspection, testing and quality control which is devised and supervised by BIS and operated by the producer. Standard marked products are also continuously checked by BIS for conformity to that standard as a further safeguard. Details of conditions under which a licence for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards. Act, 1986 and the Rules I Bureau of Indian Standards BIS is a statutory institution established under the Bureau qf India/r Standards Act, 1986 to promote marking and quality certification of harmonious development of the activities of standardization, goods and attending to connected matters in the country. . Copyright BIS has the copyright of all its publications. No part of these publications may be reproduced any form without the prior permission in writing of BIS. This does not preclude the free use, the course of implementing the standard, of necessary details, such as symbols and sizes, type grade designations. Enquiries relating to copyright be addressed to the Director ( Publications BIS. Revision of Indian Standards in in or ), Indian Standards are issued from possession of the to BIS giving the are reviewed periodically and revised, when necessary and amendments, if any, time to time. Users of Indian Standards should ascertain that they are in latest amendments or edition. 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